Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

CryoValve, Aortic Valve & Conduit

FDA Recall Z-1523-2008 · Posted 2008-09-01

Recalling FirmCryoLife, Inc.
Recall StatusTerminated
Product CodeMIE
Date Initiated2008-03-26
Date Terminated2010-01-12
Product Quantity1 tissue

Reason for Recall

Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed.

Firm Action

Hospitals were notified by letter on 3/24/2008. They were advised not to implanted the tissue and if implanted, they do not recommend explant unless medically necessary. A self addressed, stamped post card was included to confirm receipt of the notification. Serial number 8895391 was reported implanted. Serial number 8895131 was returned to CryoLife for destruction.

Root Cause

Material/Component Contamination

Distribution Pattern

Hospitals in DE, TN

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033484HUMAN HEART VALVE, CRYOVALVE SGCryolife, Inc. · 2008-02-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑